search
Back to results

Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
MSC
Sponsored by
Shandong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring Diabetes, Diabetes Medicines: Oral Hypoglycemic Drugs and Insulins., Umbilical Cord/placenta-Derived MSC, Transplantation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Free will taking part in the study and ability to provide written informed consent
  • Type 2 diabetes mellitus (as guideline WHO, 1999)
  • Age 18-80 years old, Male/Female
  • 19≤Body mass index (BMI)≤30㎏/㎡
  • Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7%
  • Intravenous insulin tolerance test(ITT)indicate patient being insulin resistance
  • Not pregnant or nursing
  • No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176 mmol/L
  • No active severe viral or fungus infection

Exclusion Criteria:

  • Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction)
  • Active infection requiring treatment
  • Unexplained febrile illness
  • Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection
  • Psychiatric condition that would limit informed consent
  • Patient has enrolled another clinical trial study within last 4 weeks.

Sites / Locations

  • Department of Hematology of the 2nd Hospital of Shandong UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

MSC and the oral hypoglycemic drugs

MSC and insulins

MSC and the combination of drugs and insulins

Arm Description

1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year.

1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year.

1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year.

Outcomes

Primary Outcome Measures

To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
To assess efficacy of MSC through comparing the change of ITT, Hemoglobin A1c, FBG, PBG, C-peptide levels and T cell subsets with that of baseline. The change of insulin resistance index(ITT) compared with baseline. Rate of reducing exogenous insulin requirement compared with baseline. The change of Fast blood glucose (FBG) and Postmeal blood glucose (PBG) compared with baseline. A reduction of ≥1% in HbA1c compared with baseline. The change of C-peptide levels compared with baseline. The change of T cell subsets compared with baseline.

Secondary Outcome Measures

To evaluate the incidence and severity of adverse events of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
To evaluate if there have occured the adverse everts such as fever, allergy, et al. and their severity.

Full Information

First Posted
August 5, 2011
Last Updated
August 8, 2011
Sponsor
Shandong University
search

1. Study Identification

Unique Protocol Identification Number
NCT01413035
Brief Title
Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes
Official Title
Safety/Efficacy Assessed Study on Transplantation Therapy Using Human Umbilical Cord/Placenta-derived Mesenchymal Stem Cells for Type 2 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Shandong University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) derived from human umbilical cord/placenta at a dose of 1.0E+6 MSC/kg for type 2 diabetes.
Detailed Description
1. Intervention Details: Biological: umbilical cord/placenta-derived mesenchymal stem cells; Drug: 1. Oral Hypoglycemic Drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. 2. Insulins. 1st transplantation: after finishing all required examines according to protocol in Day 0, umbilical cord/placenta-derived MSCs are transplanted intravenously. 2nd transplantation: after finishing all required examines in Day 90, umbilical cord/placenta-derived-MSCs are transplanted intravenously if the effects of MSC are better than that before. At the same time, patients continue taking the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins which the patients have taken for controlling the higher blood sugar from Day 0 for 1 year. But the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. 2. Detailed Description: To evaluate the feasibility and safety of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins. To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins. This study will last 2 to 3 years. Participants will be randomly assigned to receive either MSC transplant and the oral hypoglycemic drugs or MSC transplant and insulins or MSC transplant and the combination of the oral hypoglycemic drugs and insulins (experimental group) or the oral hypoglycemic drugs or insulins or the combination of the oral hypoglycemic drugs and insulins (control group). Patients will undergo MSC transplant at the start of the study on Day 0 and take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. As control, some patients take the oral hypoglycemic drugs, insulins or the combination of the oral hypoglycemic drugs and insulins for 1 year. At the same time, the dose of the oral hypoglycemic drugs and insulins should be regulated according to the level of blood sugar. After 3 months, patients will receive the second MSC transplantation. After six and twelve months from the first transplantation, patients will be evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Diabetes, Diabetes Medicines: Oral Hypoglycemic Drugs and Insulins., Umbilical Cord/placenta-Derived MSC, Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MSC and the oral hypoglycemic drugs
Arm Type
Experimental
Arm Description
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former oral hypoglycemic drugs, such as Dimethylbiguanide, Glurenorm and Acarbose, et al. and regulates the dosage for 1 year.
Arm Title
MSC and insulins
Arm Type
Experimental
Arm Description
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former insulins and regulates the dosage for 1 year.
Arm Title
MSC and the combination of drugs and insulins
Arm Type
Experimental
Arm Description
1.0E+6 MSC/kg, IV drop and repeat to apply in Day 90 if the effect of MSC is better. At the same time, patient continues to apply the former combination of the oral hypoglycemic drugs and insulins and regulates the dosage for 1 year.
Intervention Type
Biological
Intervention Name(s)
MSC
Intervention Description
1.0E+6 MSC/kg, IV drop in Day 0 and repeat to apply in Day 90 if the effect of MSC is better.
Primary Outcome Measure Information:
Title
To assess efficacy of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
Description
To assess efficacy of MSC through comparing the change of ITT, Hemoglobin A1c, FBG, PBG, C-peptide levels and T cell subsets with that of baseline. The change of insulin resistance index(ITT) compared with baseline. Rate of reducing exogenous insulin requirement compared with baseline. The change of Fast blood glucose (FBG) and Postmeal blood glucose (PBG) compared with baseline. A reduction of ≥1% in HbA1c compared with baseline. The change of C-peptide levels compared with baseline. The change of T cell subsets compared with baseline.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
To evaluate the incidence and severity of adverse events of transplantation treatment using umbilical cord/placenta-derived mesenchymal stem cells in patients with type 2 diabetes mellitus
Description
To evaluate if there have occured the adverse everts such as fever, allergy, et al. and their severity.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Free will taking part in the study and ability to provide written informed consent Type 2 diabetes mellitus (as guideline WHO, 1999) Age 18-80 years old, Male/Female 19≤Body mass index (BMI)≤30㎏/㎡ Fast blood glucose (FBG)≥7.0 mmol/L, and HbAc1≥7% Intravenous insulin tolerance test(ITT)indicate patient being insulin resistance Not pregnant or nursing No moderate or sever organ dysfunction: Ejection fraction>45%; Creatinine <176 mmol/L No active severe viral or fungus infection Exclusion Criteria: Severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction) Active infection requiring treatment Unexplained febrile illness Known immunosuppressive disease, e.g. HIV infection, or hepatitis B or C infection Psychiatric condition that would limit informed consent Patient has enrolled another clinical trial study within last 4 weeks.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
chengyun zheng, Ph. D
Phone
+86-531-85875635
Email
chengyun.zheng@ki.se, kdx2002@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
chengyun zheng, Ph. D
Organizational Affiliation
Department of Hematology of The 2nd Hospital of Shandong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Hematology of the 2nd Hospital of Shandong University
City
Jinan
State/Province
Shandong
ZIP/Postal Code
250033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
chengyun zheng, Ph. D
Phone
+86-531-85875635
Email
chengyun.zheng@ki.se, kdx2002@126.com

12. IPD Sharing Statement

Citations:
PubMed Identifier
25651730
Citation
Kong D, Zhuang X, Wang D, Qu H, Jiang Y, Li X, Wu W, Xiao J, Liu X, Liu J, Li A, Wang J, Dou A, Wang Y, Sun J, Lv H, Zhang G, Zhang X, Chen S, Ni Y, Zheng C. Umbilical cord mesenchymal stem cell transfusion ameliorated hyperglycemia in patients with type 2 diabetes mellitus. Clin Lab. 2014;60(12):1969-76. doi: 10.7754/clin.lab.2014.140305.
Results Reference
derived

Learn more about this trial

Safety and Efficacy Study of Umbilical Cord/Placenta-Derived Mesenchymal Stem Cells to Treat Type 2 Diabetes

We'll reach out to this number within 24 hrs